The Clinical Trial Site Perspective on Clinical Trial Supply

Samantha Carmichael
Contributor: Samantha Carmichael
Posted: 12/02/2013

Should companies be communicating more clearly with their site teams with regard to their expectations? We spoke to Samantha Carmichael, Lead Pharmacist Clinical Trials at NHS Greater Glasgow & Clyde to gain insight into challenges for sites from the different stages in clinical supply management.

G Clarke: Challenges in clinical trial supply vary between sites and stages in a clinical trial; what are those challenges and can these challenges be accounted for?

S Carmichael: From a site perspective, a lot of my team face different challenges day to day in terms of running multiple studies and obviously multiple stages. That can vary from the studies that send you too much stock, the studies that don't send you enough stock, the studies that might have some sort of disconnects in their supply strategies for whatever reason. At site level I think it's important to realise that there are multiple studies running for multiple sponsors and multiple organisation, so one of the challenges we do face is managing that and all the different supply mechanisms in terms of making sure we always have stock for our patients for our studies.

G Clarke: A lot of that will then involve, obviously, working closely with your suppliers to get the right amount of stock to perform all of these studies?

S Carmichael: Yes, nowadays much of it is automated, so in a lot of respects we don't have a whole lot to do in terms of the reordering process, but then the ones that maybe want us to do manual orders become less of the norm, and obviously, those ones are the ones that could slip through the net, if someone misses a reorder deadline or something like that.

G Clarke: How can you meet these challenges clear to the site, to ensure that everybody on the site knows what's involved?

S Carmichael: What we tend to request at the time of initiation is we get a look at pharmacy manuals ahead of initiations, so that when we do come to initiate and be ready to run the study we have a clear idea how that particular organisation wants us to work and how the supplies will come in, etc; what format they'll come in, what kind of acknowledgements we need to do. If we ask for that in advance of initiation, it usually means that at the initiation visit, we can iron out the finer details and raise the questions that we might want to ask rather than once we've initiated and obviously are trying to get patients on to study.

G Clarke: How can we more effectively meet patients' needs in a clinical trial?

S Carmichael: I'm not sure that many organisations or sponsors actually speak to patients directly. The Pharmacy Department is almost the last point before the patients in a lot of respects. Certainly, our organisation works as sponsor and as obviously a host site, so when we are sponsor we obviously have the insight from both sides, so we're able to try and address patient needs and site needs in a better way because of our access to the personnel, if you like, who are working with those patients or with that site directly. As a host site, I'm not really aware of ever being asked by an organisation as to input early on in the development of a project or the packaging of a project as to how that might help.

G Clarke: Do you believe there would be value in that sort of communication?

S Carmichael: Yes, absolutely. One of the things that we ask a lot as a site, as part of their dispensing process often is to add a local dispensing label, for example, to IMP. Actually, under some of the requirements and regulations for dispensing medicines we would always put a full patient name on and not just initials. You always have the place where you've got medicine dispensed on that label. We obviously have to get that approved by every single sponsor, and we always make it clear, for example, that we wouldn't cover up any of the Annex 13 compliant labels, etc, that are applied via the sponsor. Most of the time that's okay, but we do sometimes get challenges back from sponsor who won't allow us to do that. Obviously, that covers patient safety as well; should they go into another hospital holding this medicine at least you've got identifiers on it that can help someone at another hospital find out what the study is, what else they need to do for that patient.

G Clarke: Clinical trials can involve obviously large and diverse teams. What are the biggest challenges in co-ordinating communication between them and how can they be overcome?

S Carmichael: I guess one of the biggest challenges is really people's time and again just that recognition that a site label, when you're conducting a study, there's often going to be more than your study at that site and multiple stakeholders involved. So that can obviously range from your medics, your nurses, pharmacists, but also it can be labs and pathology staff if there's other samples and storage and things involved. I guess the key thing is to try and make sure that you involve people early on and get them the information they need upfront, and that ultimately helps get the study open and recruiting to time and on target.

G Clarke: What technologies do you see as having the greatest benefit to clinical trial supply in the next five years?

S Carmichael:One of the benefits I think that I've talked about quite a few times with a number of people, and I'd be really interested to developing is the use of the barcodes. Certainly, from again selfishly a pharmacist's perspective, obviously we get involved in receipting orders, dispensing the orders, doing accountability, doing patient returns, and at the moment a lot of that's all done manually; it's all handwritten records. Quite often cross-checked with an IVRS or IWRS system where we may have printouts of pack numbers and things, but I think it would be really useful to see the barcoding system develop. For example, you receipt the order, scan the barcode, dispense it, scan the barcode, do the return, scan the barcode, and it becomes more of an electronic record. Obviously, it could remain electronic with all the caveats around backups, etc, but if paper copies are required – as they still are in a lot of cases – you're having to find time when you print that out; each time you do it you might print it out, when a patient's completed the study or whatever, so that it just reduces time and effort. At the moment, it's almost a duplicate system, doing the manual one and doing the electronic one.

G Clarke: Excellent. Hopefully it certainly will make that job a lot easier. Thank you very much, Samantha, for sharing your insights and your time with us today. We look forward to hearing more from you at the Clinical Trial Supply Europe event.

Please note that we do all we can to ensure accuracy within the translation to word of audio interviews but that errors may still understandably occur in some cases. If you believe that a serious inaccuracy has been made within the text, please contact +44 (0) 207 368 9482 or email gerald.clarke@iqpc.co.uk

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Samantha Carmichael
Contributor: Samantha Carmichael
Posted: 12/02/2013

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